Kentro KTR-2492 - 13 The Paraphrase of Graphic Symbol; 14 Executive Standards; Appendix Emc Declaration

The product conforms to the following standards and laws:
1、IEC 60601-1:2005+A1：2012 Medical electrical equipment-Part 1:
General requirements for basic safety and essential performance
2、IEC 60601-1-11：2015 Medical Electrical Equipment - Part 1-11:
General Requirements For Basic Safety And Essential Performance -
Collateral Standard: Requirements For Medical Electrical Equipment And
Medical Electrical Systems Used In The Home Healthcare Environment
3、IEC 60601-2-10：2013 Medical electrical equipment - Part 2-10:
Particular requirements for the safety of nerve and muscle stimulators
4、IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General
Requirements For Basic Safety And Essential Performance - Collateral
Standard: Electromagnetic Disturbances - Requirements And Tests
The equipment is intended for use in the electromagnetic environment
specified below.
The customer or the user of the EQUIPMENT should assure that it is used
in such an environment.
The Transcutaneous Electrical Nerve Stimulators is suitable for
use in a professional health care environment, not including areas where
there are sensitive equipment or sources of intense electromagnetic
disturbances, such as the RF shielded room of an imaging system magnetic
resonance imaging, in operating rooms near active AF surgical equipment,
electrophysiology laboratories, armored rooms or areas where short wave
therapy equipment is used.
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(e.g. MRI scan room) and mobile wireless communication devices. Using
the device in an improper environment may cause malfunction or damage.
14. Executive Standards
Appendix EMC Declaration
Figure 2 Accessories of
Transcutaneous Electrical
Nerve Stimulators ,
This product is equipped
with one of the following
two remote controllers:
KTR-2491A and
KTR-2491B.
ⒻⒼ
ⒻⒽ
12.2 Remote control
KTR-2491A KTR-2491B
13. The Paraphrase of Graphic
Symbol
Symbol Explanation
Production Batch
Product catalogue reference code
Manufacturer
(Regulation (EU) 2017/745 for Medical Devices)
DATE OF MANUFACTURE. This symbol shall
be accompanied by a date to indicate the date
of manufacture
Caution
Symbol for CE Mark. This symbol certifies
that a product has met European Union
consumer safety, health, or environmental
requirements..
IP22
CE marking with the Registration Number of
the Notified Body. Regulation (EU) 2017/745
for Medical Devices
Refer to instruction manual/ booklet
Level of protection against the insertion of
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liquids in the presence of dripping water
when tilted at 15° compared with product.s.

Applied part of type BF
European Authorized Representative
Medical device
Fig 2
58
KTR-24